Implementing ISO 9001 Clause 7, which covers "Support," focuses on providing the necessary resources, personnel, infrastructure, and environment to establish, implement, maintain, and continuously improve the quality management system (QMS). Here’s how to implement this key clause effectively:
Step 1: Provide Resources
- General Resources: Identify and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of the QMS.
- People: Ensure that persons doing work under the organization’s control are competent, based on education, training, or experience.
Step 2: Ensure Competence
- Determine Necessary Competence: Identify the competence requirements for personnel performing work affecting product and service quality.
- Take Actions to Acquire Competence: This could include training, hiring qualified personnel, or mentoring existing staff.
- Evaluate the Effectiveness of Actions Taken: Assess whether the actions taken to acquire competence were effective.
- Maintain Records of Competence: Keep documented information as evidence of competence.
Step 3: Raise Awareness
- Communicate the Importance of Quality: Ensure that all employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
- Understand the QMS: Make sure employees are aware of the quality policy, significant quality objectives, and their role in contributing to the effectiveness of the QMS.
Step 4: Provide Infrastructure and Environment
- Infrastructure: Maintain the infrastructure needed to achieve conformity to product and service requirements. This includes buildings, workspace, equipment, hardware, and software.
- Work Environment: Manage the work environment needed to achieve conformity to product and service requirements. This could relate to physical, environmental, or other factors (like social, psychological, and physical).
Step 5: Monitor and Measure Resources
- General Monitoring and Measuring Resources: Determine what needs to be monitored and measured. Provide resources to ensure valid and reliable monitoring and measurement results.
- Maintain Measuring Instruments: Ensure that measuring equipment is calibrated or verified at specified intervals or prior to use, and maintained as required.
Step 6: Manage Documented Information
- Creating and Updating: When creating and updating documented information, identify appropriate description, format, review, and approval processes.
- Control of Documented Information: Ensure documented information required by the QMS and by ISO 9001 is controlled to ensure it is available and suitable for use, protected from loss of integrity and inappropriate use, and adequately maintained.
Implementing Clause 7 requires a careful analysis of what resources are essential for your QMS and ensuring those resources are provided, managed, and maintained. This support foundation is crucial for all other aspects of the QMS to function effectively.